Examination of the effects of moisturizers on basal sweating and microcirculation in patients with sebum deficiency

JRCT ID: jRCTs061210081

Registered date:02/03/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: asteatosis
• Date of first enrollment: 11/03/2022
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Subjects apply the study drug (Hildoid Cream 0.3% or Propet (White Petrolatum)) to the entire unilateral lower leg as instructed by the evaluating physician from the start of treatment until the time of visit 2 weeks after the start of treatment. If subjects participate in the follow-up period, the study medicine (Hildoid Cream 0.3% or Propet(white petrolatum)) should not be applied to the unilateral lower leg, which is the evaluation area, from the time of the visit 2 weeks later to the time of the visit 3 weeks later.

Outcome(s)

Primary Outcome

-Changes over time of basal sweating
-Changes over time in amount of change from before treatment for basal sweating
-Changes over time of blood volume
-Changes over time in amount of change from before treatment for blood volume

Secondary Outcome

-Changes over time of microvascular structure
-Changes over time in amount of change from before treatment for microvascular structure
-Changes over time of overall dry skin score
-Changes over time of pruritus NRS
-Changes over time of water content in the stratum corneum
-Changes over time of TEWL

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1)Patients who have asteatosis, with no sign of eczema lower leg on the day of the treatment start
(2)Patients 20 years and older at the time of informed consent

Exclude criteria

(1) Patients with any of the following medical histories
1) Serious allergies (shock, anaphylaxis-like symptoms)
2) Hypersensitivity to heparinoid-containing preparations
3) Hypersensitivity to PROPETO (White Petrolatum)
4) Skin hypersensitivity to topical medicines (contact dermatitis, etc.)
(2) Patients with any of the following diseases
1)Serious diseases of the heart, liver, kidneys, lungs, and blood that investigator have considered are inappropriate for participate in study.
2)Malignant tumor, except for there is no treatment and no recurrence for the past 5 years or history of curative treatment for the cervical intraepithelial neoplasia at the time of informed consent
3) Skin diseases other than the asteatosis that occur at the evaluation area of this study
4) Diseases such as hyperhidrosis and microcirculatory disorder symptoms in which the amount of sweating and blood flow are not stable
5) Hemorrhagic blood diseases (hemophilia, thrombocytopenia, purpura, etc.)
(3) Patient who are expected to become serious even if they bleed slightly
(4) Patient enrolled in this study in the past
(5) Patient participating in other clinical studies, clinical trials or post-marketing clinical trials
(6) Patient who used topical drugs (including over-the-counter drugs, quasi-drugs, and cosmetics) for the rash on the lower leg with asteatosis within 14 days before the start of treatment
(7) Patient who took oral antihistamine or oral antiallergic drug within 14 days before the start of treatment
(8) Patient who used medicine that change sweating or blood flow within 14 days before the start of treatment (excluding Chinese medicine, including off-label use hyperhidrosis medicine)
(9) Patient who took oral corticosteroids within 3 months (90 days) before the start of treatment
(10) Female patient, who be pregnant or lactating or may be pregnant
(11) COVID-19 patients (including asymptomatic pathogen carriers) or who suspected COVID-19 infection
(12) Patient who were found to have close contact with COVID-19 patients (including asymptomatic pathogen carriers) within 14 days prior to the start of treatment
(13)patient who is judged by the principal investigator or sub- investigator to be ineligible for this study for any other reason

Related Information

• Primary Sponsor: Aoyama Yumi
• Secondary Sponsor: Maruho Co.,Ltd.